Biological E. Limited (BE) walk-in interview for Executive/ Sr. Executive / Asst. Manager/ Deputy Manager- Quality Assurance department on Friday, October 18, 2024
Biological E. Limited (BE) invites experienced, dynamic, and self-motivated candidates with 2 to 12 years of experience for the following positions at its Vaccine Business in Shamirpet, Hyderabad:
QUALITY ASSURANCE:
- Position : Executive/ Sr. Executive / Asst. Manager/ Deputy Manager
Qualification: B. Pharmacy/M. Pharmacy/MSc (Life Science) / M. Tech (Life Science)
Required Skills: QA- VALIDATION & CSV
Validation, qualification and requalification of HVAC, process & packing equipment’s, utilities etc.
Preparation and review of URS, DQ, FAT, SAT & SOPs for computerised systems
Preparation and review of the computerised systems qualification protocols (IQ/OQ/PQ), compilation of the executed protocols, and writing a report
Prepare and review the System Level Impact Assessment (SLIA), 21 CFR Part 11, EU Annexure 11, checklist, and identify the qualification and validation requirements
IN PROCESS QA (IPQA)
Participation in media fill activities and process validation
Reviewing log books and handling incidents in utility areas such as HVAC, water systems, and compressed air systems
Handling investigations and changing controls
Managing in-process checks in the filling and packing area
Minimum three years of experience in a pharmaceutical GMP environment with aseptic practices (MHRA, FDA, WHO)
IT QA
Ensure quality, compliance, and productivity by building validated IT applications, process control systems, and analytical systems
Auditing computerized systems for 21 CFR Part 11, Annex 11, and GAMP requirements
Supplier assessment, software classification, IT risk assessment, and mitigation strategy for manufacturing and testing applications
GAP Assessment and Remediation procedures for new and legacy GxP systems are needed to ensure that the validation policy is in line with the Life Cycle Approach (GAMP 5)
CSV schedule management includes backup, restore, archive, time synchronisation, and periodic evaluations
Interested candidates may walk-in with an updated CV, latest increment letter and the last 3 months’ payslips, along with education and other relevant documents on Friday, October 18, 2024 from 09:30 am to 02:00 pm at Biological E. Limited, SEZ, Sy. No. 549-556, Genome Valley, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad- 500078, Telangana.
PS: If you have already attended the interview in the past 6 months or if we have already offered you a position, please do not attend.
Candidates who are unable to attend the interview may send in their CVs at [email protected]
